Apparatus and method for suturing tissue

ABSTRACT

A suturing device of the present invention is in the form a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle/suture (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle/suture upon exit from the patient&#39;s tissue, and returning the needle to a position such that the process of delivering additional sutures to the patient can be repeated. A safety shield mechanism ensures the user is protected from the needle at all times. The device of the present invention accommodates the right or left-handed user, rests comfortably in the user&#39;s hand, allows sufficient visualization of the procedure site, and permits the user to either control penetration depth of the needle or default to a device-determined depth. The present device permits the user to utilize a wrist-rotation (pivoting) suture delivery technique.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. patent applicationSer. No. 61/523,356, filed Aug. 14, 2011; U.S. patent application Ser.No. 61/595,310, filed Feb. 6, 2012, and U.S. patent application Ser. No.61/602,052, filed Feb. 22, 2012, each of which is hereby incorporated byreference in its entirety.

TECHNICAL FIELD

The present invention relates to devices and methods for suturing tissueand more specifically, relates to a handheld device that includes asuturing needle, a needle transfer (shuttle) mechanism for selectivelygripping and releasing the suturing needle and shuttling the suturingneedle between needle grippers to allow capture of the suturing needleupon exit from the patient's tissue and to allow return of the needle toits initial position, thereby allowing the suturing process to startover, and a safety shield mechanism for shielding the suturing needleduring the suturing operation including the needle transfer operation.

BACKGROUND

Needles and suture are used throughout the healthcare industry forindications such as wound and incision closure, securing catheters, andaffixing implantable meshes, and other medical apparatus. Becauseneedles represent injury and illness risks to the user, there is a needto make needle usage safer without sacrificing ease of use, performance,and cost. A medical device that can be used to safely suture the tissueof a patient is valuable and appealing to physicians, surgeons, nurses,physician assistants, military personnel, and other clinical andnon-clinical users of suture. As described herein, the present inventionovercomes the disadvantages of conventional suturing devices andprovides a device that has a number of mechanisms that not only shieldthe needle during operation but also provide a needle shuttling actionto ensure effective and complete suturing.

SUMMARY

A device according to one exemplary embodiment is a compact,light-weight handheld device that includes a needle and suture assembly,a mechanism for gripping and releasing the needle and suture assembly (a“needle transfer mechanism” or “needle shuttle mechanism”), safelycapturing the needle assembly upon exit from the patient's tissue, andreturning the needle to a position such that the process of deliveringadditional sutures to the patient can be repeated. The device of thepresent invention accommodates the right or left-handed user, restscomfortably in the user's hand, allows sufficient visualization of theprocedure site, and permits the user to either control penetration depthof the needle or default to a device-determined depth. The presentdevice permits the user to utilize a wrist-rotation (pivoting) suturedelivery technique that is familiar to a user based on experience withother surgical techniques.

In one embodiment, a device for suturing tissue includes a handleincluding a housing having a distal end and an opposite proximal end anda suturing needle having a first pointed end and an opposite second end.The device further includes a first needle gripper coupled to thehousing. The first needle gripping element being movable between a firstposition in which the suturing needle can freely move relative theretoand a second position in which in the suturing needle is held by thefirst needle gripping element.

A second needle gripping element is coupled to the housing. The secondneedle gripping element is movable between a first position in which thesuturing needle can freely move relative thereto and a second positionin which in the suturing needle is held by the second needle grippingelement.

The device includes an actuator disposed within the housing andoperatively coupled to the second needle gripping element for moving thesecond needle gripping element between the first and second positions. Asafety mechanism is coupled to the housing and configured for shieldingthe pointed end of the needle, wherein prior to insertion of thesuturing needle into the tissue, the suturing needle is held by thefirst needle gripping element and subsequent to passage of the suturingneedle through the tissue and upon activation of the actuator, thesuturing needle is released from the first gripping element and iscaptured and held by the second needle gripping element to allowretraction of the suturing needle from the tissue.

A device for suturing tissue according to one embodiment includes ahandle having a distal end and an opposite proximal end and beingrotatable (pivotable) about a first axis and a suturing needle having afirst pointed end and an opposite second end. The device furtherincludes a needle gripping mechanism disposed within the handle andincluding first and second needle grippers. The first needle gripper ismovable between a first position in which the suturing needle can freelymove relative thereto and a second position in which in the suturingneedle is securely held thereby.

A second needle gripper is coupled to the handle. The second needlegripper is movable between a first position in which the suturing needlecan freely move relative to the second needle gripper and a secondposition in which in the suturing needle is held by the second needlegripper. The device also includes an actuator disposed within the handleand operatively coupled to the needle gripping mechanism for shuttlingthe suturing needle between the first and second grippers. In a firstoperating position prior to insertion of the suturing needle into thetissue, the handle is positioned at a first acute angle relative to atissue surface and the device is configured such that movement of thehandle about the first axis from the first position to a secondoperating position in which the handle is positioned at a second acuteangle relative the tissue surface causes the suturing needle to bedriven into and through the tissue and permits capture of the firstpointed end by the second gripping element upon activation of theactuator.

A device for suturing tissue according to one embodiment includes ahandle having a distal end and an opposite proximal end and beingrotatable about a first axis and a suturing needle having a firstpointed end and an opposite second end. The device also includes aneedle gripping mechanism disposed within the handle and including firstand second needle grippers. The first needle gripper is movable betweena first position in which the suturing needle can freely move relativethereto and a second position in which in the suturing needle issecurely held thereby.

A second needle gripper is coupled to the handle. The second needlegripper is movable between a first position in which the suturing needlecan freely move relative to the second needle gripper and a secondposition in which in the suturing needle is held by the second needlegripper. In addition, an actuator is disposed within the handle andoperatively coupled to the needle gripping mechanism for shuttling thesuturing needle between the first and second grippers.

In a first operating position prior to insertion of the suturing needleinto the tissue, the handle is positioned at a first acute anglerelative to a tissue surface and the device is configured such thatmovement of the handle about the first axis from the first position to asecond operating position in which the handle is positioned at a secondacute angle relative the tissue surface causes the suturing needle to bedriven into and through the tissue and permits capture of the firstpointed end by the second gripping element upon activation of theactuator.

According to one exemplary embodiment, a device for suturing tissueincludes a handle having a distal end and an opposite proximal end andbeing rotatable (pivotable) about a first axis. The device also includesa suturing needle having a first pointed end and an opposite second end.A needle shuttle mechanism is coupled to the handle and includes a firstpart and a second part. Each of the first and second parts is movablebetween a needle release position in which the suturing needle canfreely move relative thereto and a needle retaining position in whichthe suturing needle is captured and held thereby. The second part isrotatable (pivotable) about the first axis.

An actuator is disposed within the handle and is operatively coupled tothe needle shuttle mechanism for causing the suturing needle to beshuttled between the first and second parts to permit the suturingneedle to be driven into and passed through the tissue. The device alsoincludes a safety mechanism coupled to the housing and configured forshielding the pointed end of the needle. The safety mechanism isrotatable about the first axis independent from the rotation of theneedle shuttle mechanism about the same first axis.

According to one exemplary embodiment, a device for suturing tissueincludes a handle having a distal end and an opposite proximal end andbeing rotatable (pivotable) about an axle that extends along a firstaxis, in response to rotational movement of a user's hand. The devicealso includes a suturing needle having a first pointed end and anopposite second end. A needle shuttle mechanism is coupled to the handleand including a first part and a second part. Each of the first andsecond parts is movable between a needle release position in which thesuturing needle can freely move relative thereto and a needle retainingposition in which the suturing needle is captured and held thereby. Thesecond part is rotatable (pivotable) about the first axis.

The device also includes an actuator disposed within the handle andoperatively coupled to the needle shuttle mechanism for causing thesuturing needle to be shuttled between the first and second parts.Wherein prior to insertion of the suturing needle into the tissue, thehandle is positioned at a first acute angle relative to a tissue surfaceand the device is configured such that rotation of the handle about thefirst axis to a different position, in which the handle is positioned ata second acute angle relative the tissue surface, causes the suturingneedle to be manually driven into and through the tissue and permitscapture of the first pointed end by the second part upon activation ofthe actuator.

The present invention is also directed to a method for suturing tissueusing one device described herein. The suturing action is performed inpart by rotating (pivoting) the handle about and axis of the device fromone position to another position and in particular, the first and secondpositions can be positions at which the handle is at an acute anglerelative to the tissue.

BRIEF DESCRIPTION OF DRAWING FIGURES

FIG. 1 is a side elevation view of a suturing device according to oneexemplary embodiment;

FIG. 2 is a side perspective view showing internal components of thedevice of FIG. 1;

FIG. 3 is a side perspective view showing internal components of thedevice of FIG. 1;

FIG. 4 is a side perspective showing, in close-up, a needle transfer(shuttle) mechanism according to one exemplary embodiment and located ata distal end of the device;

FIG. 5 is a side and end perspective view of the distal end of thedevice including the needle transfer mechanism;

FIG. 6 is a side perspective view of a needle clamping member accordingto one exemplary embodiment and part of the needle transfer mechanism ofFIG. 4;

FIG. 7A is a side elevation view of the device in a first positionillustrating a safety shield mechanism for shielding a suturing needle;

FIG. 7B is a side elevation view of device in a second position in whichthe device, including the safety shield mechanism, has been rotated andthe suturing needle is in position for penetrating tissue;

FIG. 7C is a side elevation view of device in a third position in whichthe device has been further rotated and the suturing needle passesthrough the tissue and is captured by the needle transfer mechanism;

FIG. 7D is a side elevation view of the device in which the device isfurther rotated and the needle transfer mechanism is activated toextract the suturing needle from the tissue;

FIG. 7E is a side elevation view of the device in which the needletransfer mechanism is activated to return the needle to an initialposition, thereby allowing the user to deliver another suture to thepatient;

FIG. 8A is a side elevation view of inner components of the device in aninitial position in which the suturing needle is ready for delivery tothe patient;

FIG. 8B is a close-up cross-sectional view of a needle transfermechanism according to one embodiment and in a needle transfer positionin which the suturing needle can be shuttled;

FIG. 8C is a side elevation view of the device showing the needletransfer mechanism is activated and a portion of the needle transfermechanism captures the suturing needle;

FIG. 8D is a side elevation view of the device showing a release of theneedle transfer mechanism, thereby causing the captured suturing needleto be extracted from the tissue;

FIG. 8E is a side elevation view of the device showing subsequentactivation of the needle transfer mechanism to return to the suturingneedle to the initial position;

FIG. 8F is a side elevation view of the device showing a release of theneedle transfer mechanism to return the needle transfer mechanism toreturn to the initial rest position;

FIG. 9A is a front elevation view of the distal end of the deviceshowing a safety shield mechanism according to one exemplary embodimentaccording to one embodiment;

FIG. 9B is a rear elevation view of the distal end of the device showingthe safety shield mechanism;

FIG. 10 is a partial side elevation view of the device showing aninternal cutter mechanism according to one exemplary embodiment;

FIG. 11 is a partial side elevation view of the device showing aninternal cutter mechanism according to another embodiment;

FIG. 12 is a top plan view of a portion of one safety shield showing analignment feature thereof being used in an exemplary application;

FIG. 13A is a side elevation view of the inner components of a lockoutfeature for use in the suturing devices of the present invention,wherein the lockout feature is shown in the locked position;

FIG. 13B is a side elevation of the lockout feature of FIG. 13A is adeactivated (unlocked) position;

FIG. 14 is side elevation view of the inner components of a suturingdevice in accordance with another embodiment of the present invention,wherein an actuator of the device is shown in a first (home) position;

FIG. 15 is a side elevation view of the suturing device of FIG. 14 withthe actuator being shown in a partial stroke position;

FIG. 16 is a side elevation view of the suturing device of FIG. 14 withthe actuator being shown after a full stroke position; and

FIG. 17 is a side elevation view of the suturing device of FIG. 14 withinternal guide channels (grooves) for controlling movement of thevarious pins employed in the suturing device.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

The present invention is directed to devices and methods for safelysuturing tissue, skin, muscle, ligament, tendon and similar structures.Healthcare workers need a safe device and method for closing wounds andincisions and for securing catheters to a patient. The current proceduretypically consists of a user grasping an unprotected needle and suturewith hemostats, a needle driver, or forceps and then piercing thepatient's tissue by utilizing hand and wrist movements. In thisscenario, the needle point is exposed to the user throughout theprocedure and provides risk for accidental needle stick injuries (NSI)to the user and procedural staff. These NSIs can transmit blood bornepathogens such as hepatitis and HIV to the user and others from thepatient and potentially cause illness or death. Users that are injuredin this manner are required to report the injury, undergo diagnostictests and begin receiving prophylactic treatment. They may also berequired to take a leave of absence from work or continue indefinitelywith a prescribed drug regimen.

As described in great detail below, a device according to the presentinvention is a compact, light-weight handheld device that includes aneedle and suture assembly, a mechanism for gripping and releasing theneedle and suture assembly (a “needle transfer mechanism” or “needleshuttle mechanism”), safely capturing the needle assembly upon exit fromthe patient's tissue, and returning the needle to a position such thatthe process of delivering additional sutures to the patient can berepeated. The device of the present invention accommodates the right orleft-handed user, rests comfortably in the user's hand, allowssufficient visualization of the procedure site, and permits the user toeither control penetration depth of the needle or default to adevice-determined depth. The present device permits the user to utilizea wrist-rotation suture delivery technique that is currently employedfor securing a catheter, closing a wound, or in related procedures.

The suturing device of the present invention offers a number ofadvantages compared to other conventional suturing devices. Thefollowing are merely some of the advantages provided by the presentdevice: (1) safety: the user cannot contact the point of the needle andis able to avoid accidental NSIs and the human and financial costsassociated with those accidents; (2) performance: the device allows theuser to reproduce the needle motion that is currently used by healthcareworkers. This improves the accuracy and integrity of the securement andreduces the trauma to the patient; (3) size: the device is sized andoriented for easy access to crowded and narrow regions of the patient'sbody such as the neck; (4) ease of use: the device can be generallyoperated with one hand and multiple sutures are able to be secured tothe patient through a minimal series of steps; (5) cost: the device isdesigned as a single use device that is economical and easy tomanufacture; (6) versatility: the device is suitable for use within ahospital environment and any first aid setting. It can be utilized tosecure nearly every type of catheter and to close wounds. In addition,it may be packaged within catheter and medical accessory sets or as astand-alone device.

In one exemplary embodiment, the suturing needle within the presentdevice can be returned to its starting point after it crosses thepatient's tissue so that the device can be used to repeat the needledelivery process. At the conclusion of the process, the suturing needleis safely retained by the needle transfer mechanism within the device,which can then be safely disposed. In one exemplary embodiment, safetyfeatures (include the safety shield mechanism) are incorporated into thesuturing device such that the user cannot come into contact with thesuturing needle before, during, and after the procedure. In addition, anintegral cutter is preferably incorporated into the suturing device inorder that the suture can be cut by the user without the need forscissors or a scalpel.

Although in one embodiment, the present device is intended to be asingle-use device, it is understood that slight alterations can be madeto the design and materials that would allow said device to beresterilized, reloaded with an additional needle and suture assembly,and reused.

The suturing device includes a handle, which as described in detailbelow, is comprised of one or more components and can be molded, cast orextruded from a variety of materials including but not limited topolymers or metals. Examples of polymers suitable for fabricating thehandle are thermoplastics and thermosetting materials such aspolystyrene, acrylic, polycarbonate, polyamide, polyester,polyetherimide, polysulfone, polylactic acid, polyvinylchloride,polyolefins, polyurethane, fluoropolymers, and copolymers and alloysthereof. These materials may be filled with glass or other usefulreinforcing agents in order to enhance their mechanical properties.Suitable metals come from but are not limited to a group includingtitanium alloys and stainless steel. The selected materials must meetphysical and mechanical performance requirements and be able towithstand sterilization methods employed within the medical deviceindustry such as ethylene oxide or gamma irradiation.

According to one exemplary embodiment, the needle assembly generallyconsists of a suturing needle and a suture attached thereto. Thesuturing needle includes a distal pointed end suitable for piercing andcrossing tissue and a blunt proximal end suitable for affixing a suture,and a body between the distal and proximal ends. The suturing needle canbe fabricated in a variety of configurations from straight to curved andbe monolithic or of a multi-part construction. The outer diameters ofthe needles can be round or non-round, tapered, or possesses featuresthat assist in advancing and gripping the needle. Needles are commonlymade from stainless steel and related alloys but can be made from othermetals, polymers and ceramic materials that are sufficiently rigid,capable of possessing and sustaining a functionally sharp distal point,and able to bond to suture. Traditionally, sutures are affixed to theproximal end of metal needles by swaging, crimping, and adhesives.Suture attachment can also be configured such that the suture is affixedto the other regions of the needle, yet not the proximal terminus. Thisdesign variant provides additional freedom for suture management andgripping the needle in the device handle. Coatings on the needle serveto enhance the lubricity of the needle and reduce tissue penetrationforces.

The suture is the thread-like structure that is used to close wounds andincisions or to secure catheters or other components to patients. Thesuture can come in a variety of diameters, textures, forms, i.e., singlestrand or braided, and materials depending upon the desired propertiesand intended application. Sutures can be absorbable, i.e., collagen,polyglactin, polydioxanone, polyglycolide-lactide copolymers, ornon-absorbable, i.e., silk, nylon, polyester, polypropylene. Sutures canbe treated with antimicrobial, bioabsorbable, hydrophilic or otherfunctional additives. In addition, sutures can be textured with raised“unidirectional” features, which permit the suture to pass easilythrough tissue when drawn in one direction, however, impedes the suturefrom being pulled out of the tissue when it is drawn in the reversedirection.

The interfaces between the handle and the suturing needle/suture aregenerally referred to as the mechanisms or assemblies. These mechanismsserve to grasp, release, and shuttle the needle by manipulations to thehandle by the user or by otherwise manipulating the device to cause theneedle transfer. As will be appreciated from the below detaileddescription, there are a number of mechanical mechanisms that can beused to produce the desired movement of the suturing needle and morespecifically, produce a reciprocal needle transfer action in which thesuturing needle is initially held in one position within the mechanismand is then caused to be moved to another position within the mechanismto effectuate the suture needle passing into and through the tissue andthen being subsequently extracted from the tissue. Further, afterextraction, the mechanism is preferably designed to pass the suturingneedle back from the needle capture/extraction position to the initialposition at which the process can be repeated. Thus, one mechanism canbe thought of as being a mechanism for cycling the suturing needlebetween different positions that result in the desired suturing action.

It will thus be appreciated that a variety of mechanisms that are ableto grasp, release, and shuttle the needle can be used. The mechanismsinclude but are not limited to rack and pinion, gearing, cams, ramps,screw bodies, springs, multiple-point gripping structures, i.e.,3-point, collets, drive belts, and rigid and flexible push rods to namea few. In instances, the suturing needle can comprise physical featuresthat correspond to engagement features found within these mechanisms inorder, for example, to increase grip strength. Some examples of thesefeatures are indentations, serrations, projections, faces, flats,undercuts, rings, and ports.

Moreover, the present device preferably includes a safety shieldmechanism, which protects the user from the needle point before, during,and after the suturing procedure. The safety shield mechanism can existin numerous forms in that any number of different mechanicalarrangements can be used to accomplish the intended function. The safetyshield mechanism can comprise single or multiple components, be biasedto a safety-mode position and/or be user actuated, and/or havereversible or irreversible lock-out features as described furtherherein. The safety shield mechanism can be configured, for example, as aslideable or rotatable cover, or as deflectable wing-like shields thatobstruct user access to the needle point. Similar to the handledescribed above, the safety shield mechanism cans be made from a widerange of thermoplastics and thermosetting polymers; however, atransparent polymer may be more desired as it would provide the userwith greater visibility of the needle and suturing site. Furthermore,the safety shield mechanism can be manufactured from metals, such asstainless steel, titanium, and titanium alloys includingnickel-titanium, and configured as a wire-form, mesh, grid, or strut. Aspring or other force-resilient components can be incorporated in orderto bias the safety apparatus into a safe position or to actuate multiplecomponents that comprise the safety apparatus.

Finally, a suture cutter is preferably located within the device handleso that the user can trim knotted sutures and suture strands to length.One exemplary cutter can be a dynamic shearing apparatus, i.e., scissorsor slideable blade(s), that requires the user to press or slide a buttonor manipulate an actuator having a different form, such as a knob orlever, in order to actuate the blade to cut the suture. To this end, thesuture(s) can be positioned in a notch, slot, or hole located on thehandle, and the actuation of the sharpened blade would cut thesuture(s). Upon cutting the suture, a spring or similar component wouldreturn the blade to its original position such that the cutting processcan be repeated. Alternatively, the cutter can be a simple apparatussuch as a static cutting blade located in a narrowing, crevice-likefeature on the handle. In this configuration, the suture could be drawnacross the sharp edge of the blade in order to cut it. Typical materialsthat are useful as cutting blades are stainless steel, carbon steel, andgemstones, such as diamond. For safety purposes, the user does not havedirect access to the cutting blade; only suture is able to reach theblade via the suture cutter notch or hole. Beyond the safety advantage,the integral cutter would reduce or eliminate the need for the user toprovide a separate pair of scissors for cutting or trimming sutureduring the procedure.

It will be appreciated that the above-described structures constituteexemplary parts of one suturing device according to the presentinvention and each of these structures is described in greater detailbelow. The foregoing discussion is thus a brief summary of suitableparts that can be present within the present suturing device; however,are not to be considered to be limiting of the scope of the presentinvention. The make-up and operation of various exemplary suturingdevices in accordance with the present invention are now described.

FIGS. 1-6 illustrate a suturing device 100 according to one exemplaryembodiment. The suturing device 100 is formed of a number ofcomponents/parts, assemblies and mechanisms that operate to perform theintended suturing action as described herein.

The suturing device 100 includes a housing that contains a number of theworking components and allows a user to easily hold and use the device100. For example and as shown in the illustrated embodiment, the housingcan be in the form of an elongated handle that is formed of a first part110 and a second part 120. The first and second parts 110, 120 arecomplementary to one another and include a means for attaching the twoparts together to form an assembled handle that can be easily graspedand manipulated by the user. For example, the first and second parts110, 120 can be attached to one another by a mechanical attachment, suchas by using fasteners, by establishing a snap-fit between the two parts,etc. The handle not only houses many of the working components but alsoprovides a means for the user to grasp the device 100 but alsomanipulate it in such a way to cause the needle 101 to be advanced intoand through the tissue 10 and then exists the tissue 10.

Each of the first and second parts 110, 120 is generally hollow andtherefore, when the two handle parts 110, 120 are attached to oneanother, they define a hollow interior handle space that receives andholds many of the working components of the device 100 as will beappreciated below. The first part 110 is an elongated handle partdefined by a proximal end (upper end) 112 and a distal end (bottom end)114 and similarly, the second part 120 is an elongated handle part thatis defined by a proximal end (upper end) 122 and a distal end (bottomend) 124. The handle can include ergonomic gripping regions/surfaces 109suitable for both left and right-handed users to facilitate grasping ofthe device 100. As shown, these gripping regions 109 can be in the formof locally recessed and contoured portions of the handle that locate andpermit a user's thumb/fingers to grasp the exterior of the device 100.The gripping regions 109 can alternatively be defined by a modifiedexterior surface of the housing parts 110, 120 within local handlesections that allow the user to more easily grasp the handle. Forexample, the exterior surface of the handle can be a rough surfacedefined by surface features, such as a plurality of raised bumps or thelike or can even be defined by a material that is different than thematerial of the handle and is applied thereto (e.g., a gripping surfacemember applied to the handle by means of an adhesive or over-moldingprocess or other suitable process).

As shown in the figures and described in detail herein, the suturingdevice 100 is configured to move a curved suturing needle 101 in acontrolled manner such that the suturing needle is advanced into andthrough target tissue 10 and is then extracted from the tissue 10 tocomplete one suturing action and allow the user to tie off the sutureelement itself. As mentioned herein, any number of different types ofsuturing needles 101 can be used with the device 100. In general, thesuturing needle 101 includes a sharp distal end 103 for penetrating thetissue 10 and an opposite proximal end 105 (see, FIG. 4) which istypically a blunt end.

The device 100 also includes an actuator assembly that is used tooperate the device 100 and to effectuate the controlled movement(shuttle action) of the suturing needle 101. The actuator assemblyincludes an actuator body 200 that is accessible to the user and ismanipulated by the user to cause controlled movement of the suturingneedle 101. In the illustrated embodiment, an upper end 202 of theactuator body 200 extends beyond the proximal end of the handle and isaccessible by the user. The actuator body 200 is operatively coupled toother parts of the actuator assembly to cause the desired controlledmovement as described hereinbelow and in particular, causes needletransfer to effectuate the suturing action.

It will be appreciated that the illustrated actuator assembly is merelyone exemplary type of actuator that can be used in the present device100 to cause controlled movement of the suturing needle 101 and thereare a number of other actuator assemblies that can be used for causingthe needle to be transferred (shuttled) in the manner described herein.For example, while the actuator body 200 is moved linearly by the user(e.g., as by pressing down on the end 202 of the body 200), otheractuators suitable for use in the present invention can be activated byother techniques, such as pressing a button, rotating an actuatorelement, etc.

In the illustrated embodiment, the actuator body 200 is connected to aneedle transfer mechanism 400, which as mentioned herein, is designed tocontrollably move the needle 101 from one operating position to anotheroperating position and more specifically, to transfer the suturingneedle 101 from one needle transfer structure (member) to another needletransfer structure (member) to allow the suturing needle 101 to beextracted from the tissue 10 once it passes therethrough. The connectioncan be achieved by using a linkage, such as by using a link arm 270 thatis coupled to the actuator body 200 at one end thereof. In particular,the handle part 120 can include a feature, such as a protrusion (boss)210, that is received within an opening 272 formed in one end of thelink arm 270, thereby defining a pivot between the link arm 270 and thebody 200. Movement of the actuator body 200 is translated into movementof the link arm 270 to thereby drive the needle transfer mechanism 600and in the illustrated embodiment, the link arm 270 is depressed andcauses the link arm 270 to move downward. The link arm 270 includes anopening 274 at a distal end that is configured for coupling the link arm270 to the needle transfer mechanism 600.

In accordance with one embodiment, the actuator assembly includes adrive mechanism 225 for generating a return force that is applied to theactuator body 200 to automatically return the actuator body 200 to arest position upon release of the actuator body 200. As a result, thedrive mechanism 225 can be thought of as at least partially being areturn mechanism that returns the actuator body 200 to its originalposition when the actuator force applied to the actuator body 200 isremoved. It will be understood and appreciated that the illustrateddrive mechanism 225 is merely one type of mechanism for returning theactuator body 200 to the rest position and there are many othermechanical arrangements that can accomplish the same movement and samefunction as the mechanism 225. The drive mechanism 225 includes a firstrack 220 that is carried by the actuator body 200 and therefore, movesin unison therewith, and a second rack 240 that is fixedly coupled tothe handle part 120. Each of the first and second racks 220, 240includes a series of teeth.

The illustrated drive mechanism 225 is based on applying a biasing forceto the actuator body 200 to cause the actuator body 200 to normally (ina rest position) assume an upward position (see FIGS. 1-2). The biasingforce is generated by a biasing member, such as a spring (not shown)that exerts a biasing force that is applied to the actuator body 200 todrive the actuator body 200 upward.

The biasing force can be generated by a spring that is disposed within aspring housing 250 that contains the spring and also includes arotatable gear 235 that meshes within the teeth of the racks 220, 240for controlled linear movement of the actuator body 200 as the body 200is depressed by the user and when a return force is automaticallygenerated to return the actuator body 200. A return spring guide 230 isdisposed between the housing 250 and an undercut wall 204 of theactuator body 200. The return spring guide 230 seats flush against thewall 204 and therefore a force applied to the wall 204 results in adriving of the actuator body 200 in an upward direction to return it toits normal rest position. When the user applies a downward force toactivate the actuator assembly, this applied force overcomes the biasingforce generated by the spring and thus, the actuator body 200 can bedriven downward by the user, thereby causing the desired movement of thelink arm 270 (in this case, driving the link arm 270 in a downwarddirection). The illustrated drive mechanism 225 also includes a drivefinger 260 is disposed within the housing 250 at a lower end thereof andis configured to move as the actuator body 200 moves in the mannerdescribed herein and is configured to allow for rotation of the needletransfer mechanism 400 and permit both capture and return of the sutureneedle 101 to the original positions.

In accordance with one embodiment, the device 100 includes a number ofgears that engage one another to translate movement of the actuator body200 into movement of the needle transfer mechanism 400. For example, thedevice 100 can include a first gear 300 that is rotated due to movementof the actuator body 200 and as described below is configured to impartmovement to the needle transfer mechanism 400. The first gear 300 isrotatably coupled to the handle housing (i.e., handle part 120) and caninclude features that are contacted by the drive mechanism 225 forimparting movement of the needle transfer mechanism 400 as describedbelow. For example, the first gear 300 can include upstanding posts(protrusions) (not shown) that are contacted by a part of the drivemechanism (e.g., drive finger 260) or the first gear 300 can otherwisebe contacted/engaged by a part of the drive mechanism 225, such as bythe drive finger 260 or other structure during the downward movement ofthe actuator body 200 to cause a rotation of the first gear 300. Thedrive mechanism 225 is configured such that one actuator cycle movementdefined by pressing the body 200 downward to its end of travel causesthe drive finger 260 to be driven into engagement with one postassociated with the first gear 300 resulting in the first gear 300making a ¼ rotation. In other words, there can be four posts on thefirst gear 300 representing four ¼ rotation cycles such that eachactuator cycle (unit 200 being pressed down and then released) resultsin the first gear 300 turning a ¼ rotation. This is merely one exemplaryway of obtaining controlled movement of the first gear 300 by means ofmovement of the actuator assembly.

The device 100 also includes a second gear 310 which meshes with thefirst gear 300 and is located more distal relative thereto. The secondgear 310 is also supported by the handle and in particular is rotatablycoupled to one of the handle parts 110, 120.

The second gear 310 is intimately meshed with a third gear 320 which isin the form of a cam gear 320 which is associated with (coupled to) acam shaft 340 (in one exemplary gear ratio, the gear 300 moves ¼ turnper actuation, while the gear 320 rotates ½ turn). More specifically,the cam shaft 340, which can be thought of as an axle, is located at thedistal end of the handle and defines an axis about which not only thehandle (parts 110, 120) can rotate but also defines an axis about whichother parts of the devices can rotate as described herein. Inparticular, in one embodiment, the axis defined by the cam shaft 340defines an axis of rotation of both the needle transfer mechanism 400and the safety shield mechanism 600. The cam shaft 340 is supported bythe handle parts 110, 120 and extends generally perpendicular thereto.By defining an axis of rotation for the handle itself and thus thedevice 100 itself, the device 100 is designed to rotate about the camshaft 340 during use of the device 100 in order to initially positionthe device 100 and then advance the suturing needle 101 into contactwith the tissue 10 and then through the tissue 10. This rotation is incontrast to some conventional suturing devices in which the handle isheld stationary and the needle is manipulated to cause movement of theneedle through the tissue and, as described herein, this constructionallows the device 100 to capitalize on traditional rotation of a wristof the user to cause advancement of the suturing needle 101.

In one aspect and as described herein, the device 100 is thus positionedon target tissue 10 and the suturing action occurs by the user rotatinghis or her wrist to directly cause the device 100 to move (pivot)relative to the tissue, thereby causing the suture needle 101 to followan arcuate path into and through the tissue 10. It will be appreciatedthat one typical pathway of the needle 101 is a compound arc, which hasthe needle starting out perpendicular and then rotating on a smallerradius in order to create a shallower skin penetration.

The device 100 includes a means for controlling the gear movement and inparticular, prevents the gears from reversing their direction. In oneembodiment, the means is in the form of a pawl 280 that cooperates witha ratchet member 290 to ensure that the gears do not reverse direction.In the illustrated embodiment, the ratchet 290 engages the first gear300, while the pawl 280 engages the posts that are associated with andextend from the first gear 300. The pawl 280 and ratchet 290 aresupported by the handle housing and move relative thereto toperiodically and sequentially engage one gear (in this case, the firstgear 300) such that all three gears 300, 310, 320 cannot reverse theirdirection. This results in the needle transfer mechanism 400 moving andoperating in a controlled manner.

The cam shaft 340 includes a cam (cam body) 350 located therealong. Thecam 350 is designed in part to cause selective movement of parts of theneedle transfer mechanism 600 depending upon the location of the cam350. The cam action of the shaft 340 is described in detail below andits cooperation with the parts of the needle transfer mechanism 400serves to allow both secure grasping (holding) of the suturing needle101 and a clean transfer or shuttle action of the suturing needle 101from a position prior to advancement into and through the tissue to aposition in which the suturing needle 101 is extracted from the tissue10.

The needle transfer mechanism 400 functions as a needle shuttlemechanism as described above and more specifically, is configured tograsp the suturing needle 101 in one of a number of different operatingpositions depending upon the position of the device 100 and the suturingstage of the device 100. More specifically, the needle transfermechanism 400 includes a number of parts that are designed to grasp afirst portion of the suturing needle 101 prior to advancement of thesuturing needle 101 into the tissue 10 and then subsequently grasp asecond portion of the suturing needle 101 after the suturing needle 101passes through the tissue 10 and is captured by the needle transfermechanism 400 for extraction of the suturing needle 101 from the tissue10.

In the illustrated embodiment, the needle transfer mechanism 400includes a first needle gripper 410 and a second needle gripper 420. Thefirst needle gripper 410 can be in the form of a needle grippingassembly or a needle gripping structure (member) 410 and the secondneedle gripper 420 can be in the form of a needle gripping assembly or aneedle gripping structure (member) 420. It will therefore be understoodthat a “needle gripper” can be formed of a single part or be in the formof an assembly of several parts that provide a needle gripping structurethat selectively grasps and holds the suturing needle 101 and therefore,while one or more of the illustrated needle grippers are formed as anassembly of several parts, it is within the scope of the presentinvention that the needle gripper can be constructed of a single partthat performs the function described herein.

The first needle gripper 410 includes a housing that receives a firstreciprocating part 500 that contacts the cam member 350 and isselectively moved as the cam member 350 rotates about the shaft 340. Thehousing of the first needle gripper 410 includes a first end that has anotch or recess (track) 412 formed therein and includes an end 414 thatis disposed proximate the shaft 340. The first needle gripper 410 iscoupled to the handle and the notch 412 in combination with a notchformed in the handle part 120 defines a first needle receiving space forselectively receiving the suturing needle 101 when the firstreciprocating part 500 is in a needle receiving (open) position.

In the illustrated embodiment, the first needle gripper 410 is a fixedpart in that the housing thereof does not move relative to the handle(i.e., it does not rotate relative to the cam shaft 340). However, thefirst reciprocating part 500 is movable between the needle receiving(open) position in which the suturing needle 101 can freely moverelative to the first needle gripper 410 and a needle grasping (closed)position in which the suturing needle 101 is grasped and held by thefirst needle gripper 410.

As shown in FIG. 6, in one embodiment, the first reciprocating part 500is in the form of a clamp pin that is biased relative to the cam shaft340 and in particular, relative to the cam member 350 thereof and isreceived within the first gripper 410. The first reciprocating part 500is in the form of an elongated pin that includes a first end 502 and anopposite second end 504. The first end 502 can be in the form of anenlarged head and the part 500 includes a shaft portion that is oflesser dimension that the head. For ease of illustration, the part 500is described and referenced herein as being pin 500; however, othernon-pin like structure can be equally used and therefore, the referenceas being a pin is not limiting. The shaft includes an opening, notch orslot 510 that is formed therein and is sized and configured to receivethe suturing needle 101. When the first reciprocating pin 500 is in theneedle receiving position, the notch 510 is in the open (needlereceiving) position in which the suturing needle can freely travelwithin the notch 510. Conversely, in the closed position, the suturingneedle 101 disposed within the notch 510 is not free to move relative tothe pin 500 but instead, the suturing needle 101 is firmly grasped bythe pin 500 by being intimately disposed between the pin 500 and anunderlying structure of the first needle gripper 410 (the needle is heldwithin the channel 412).

In accordance with the present invention, the pin 500 is biased relativeto the cam shaft 340 (and the cam 350). For example, a biasing element(not shown in FIGS. 1-6) in the form of a spring that is disposed aboutthe pin 500 and causes the pin 500 to be biased relative to the camshaft 340. In the illustrated embodiment, the pin 500 is biased towardthe cam shaft 340; however, it will be appreciated that the pin 500 canbe biased in a direction away from the cam shaft in another embodiment.In a rest position, the pin 500 is thus in a closed position in that thepin 500 is biased toward the cam shaft 340 and the needle 101 is held inplace since it is received within the notch 510 and the pin 500 isbiased inward thereby closing the space between the pin and the firstneedle gripper 410 that defines the notch 510 intimately contacts andapplies a force against the suturing needle 101 so as to grasp thesuturing needle 101.

The housing of the first gripper 410 includes an opening that is formedwithin the notch 412 and allows the shaft of the pin 500 to extendthrough so as to position at least a portion of the pin 500 within thenotch 412 that receives a portion of the suturing needle 101. The pin500 is positioned within the hollow interior of the first gripper 410such that the needle receiving notch 510 thereof is in registration withthe notch 412, thereby allowing the suturing needle 101 to pass throughthe notch 412 and through the notch 510 of the pin 500.

The second needle gripper 420 is similar to the first needle gripper 410in that the second needle gripper 420 is intended to selectively graspand hold a portion of the suturing needle 101 depending upon theparticular stage of the suturing operation. The illustrated secondneedle gripper 420 includes a needle gripper body or housing 440 thathas a first needle receiving end that includes a notch or recess (track)442 formed therein. The notch 442 is similar or identical to the notch412 of the first gripper 410 and is designed to freely receive thesuturing needle 101 when a second pin 500 is in one of its operatingpositions (i.e., the needle receiving or open position). In theillustrated embodiment, the notches 412, 442 are V-shaped notches formedin the end that is further from the shaft 340 and cam member 350.

It will be appreciated that the shape of the notch 412 and the shape ofthe pin 500 are selected in view of one another to provide an effectivegripping interface between the two at the location at which the two arein intimate contact. For example, the interface is defined between theV-shaped notch 412 and the needle portion which can have a trapezoidalshape, thereby creating a matched fit between the two structures. Itwill be appreciated that the shapes of the notch 412 and needle 500 canbe different so long as preferably there is the above-described matchfit between the two resulting in an effective needle gripping location.The shape of the needle also facilitates the intimate engagement betweenthe pin 500 and the needle 101 since a face (e.g., a flat surface) ofthe pin 500 can intimately contact a complementary face (e.g., a flatsurface) of the suturing needle 101, thereby securely holding the needlein the respective channel.

As with the first needle gripper body 410, the second needle gripperbody 440 has an open bottom to allow the second pin 500 containedtherein to be in intimate contact with the cam member 350 and the body440 has an opening formed in the notch 442 that allows passage of thepin 500 therethrough. The second needle gripper body 440 is alsoconfigured to be operatively coupled to the link arm 270 to therebyprovide a means for transferring the movement of the actuator body 200into movement of the second needle gripper 420. Thus, unlike the firstgripper 410, the second gripper 420 is a movable gripper that can moveto different positions and in different directions as described herein.Any number of different means can be used to couple the link arm 470 tothe second needle gripper 420 and in the illustrated embodiment, thesecond needle gripper body 440 includes a protrusion (boss) that isreceived within the opening 274 that is located at the distal end of thelink arm 270. This arrangement allows the second gripper 420 to rotaterelative to the cam shaft 340 upon activation of the actuator and inparticular in response to movement of the actuator body 200. As a resultof the above arrangement and mechanical coupling of parts, the downwardand upward movement of the actuator body 200 causes a pivoting of thesecond needle gripper 420 about the cam shaft 340. As described hereinand appreciated by viewing the figures, downward movement of theactuator body 200 is translated into pivoting of the second needlegripper 420 in a direction away from the handle and toward the distalend of the device 100. Conversely, when actuator body 200 is moved in anupward direction, the second needle gripper 420 pivots about cam shaft340 in the opposite direction (i.e., in a direction back towards thehandle).

As mentioned above, the pins 500 are biased and in the illustratedembodiment, are biased towards the cam shaft 340. However, in anotherembodiment, the pins 500 are biased in the opposite direction (i.e., ina direction away from the cam shaft 340). In both embodiments, the pins500 are moved as the cam member 350 makes contact with the pins 500 asthe cam member 350 rotates about the shaft 340. Contact with the cammember 350 thus urges the respective pin 500 in a desired direction. Ineither embodiment, the suturing needle 101 is freely to move relative tothe pin 500 and thus be both initially received and subsequently free tobe released from the pin 500 when the pin 500 is in the open positionand conversely, when the pin 500 assumes the closed position, thesuturing needle 101 is grasped by the respective needle gripper.

The second needle gripper 420 also can include a side plate 430 that iscoupled to the needle gripper body 440 so as to cover the couplingbetween the link arm 270 and the needle gripper body 440 and alsoprovides a means for coupling the second needle gripper 420 to the camshaft 430. More specifically, the side plate 430 has a distal endportion that includes an opening 432 that receives the cam shaft 340. Asshown, the opening 432 can be surrounded by an annular shaped wall orflange that contacts yet is rotatable about the cam shaft 340. The sideplate 430 is located adjacent the cam member 350, while the first needlegripper body and the second needle gripper body are adjacent the cammember 350 since the pins 500 contained therein are in contact with thecam member 350.

The safety shield mechanism 600 is configured to shield the suturingneedle 101 during the operation of the device 100 and the controlledmovement of the suturing needle 101, thereby protecting the user fromundesired contact with the suturing needle 101. In the illustratedembodiment, the safety shield mechanism 600 is formed of a pair ofsafety shields 610, 620 that are freely movable relative to the handleand are positioned and constructed such that as the suturing needle 101is advanced into the tissue 10 and then subsequently exits the tissue 10and is captured by the needle transfer mechanism 400, the safety shields610, 620 shield the sharp end 103 of the suturing needle 101. Eachsafety shield 610, 620 can be in the form of a safety shield member(structure) or can be in the form of a shied assembly formed of severalparts that in combination shield the needle 101 and move in the mannerdescribed herein.

The safety shields 610, 620 are preferably biased so as to assume thedesired position as the device 100 is used in the manner describedherein. More specifically and according to one exemplary embodiment, thesafety shield 610 has a structure that surrounds the suturing needle 101so as to prevent easy, direct access thereto. The illustrated safetyshield 610 includes a pair of side supports 612, 614 with a bottomsupport extending therebetween and containing an opening (slot or notch)to permit the suturing needle 101 to pass therethrough as the suturingneedle 101 moves relative to the safety shield 610. As shown, the safetyshield 610 is preferably a simple structure and therefore, the sidesupports 612, 614 can be substantially hollow and include openingsformed therein. The bottom support also serves to space the two sidesupports 612, 614 apart from one another.

The safety shield 610 is biased with a biasing member, such as a spring,to thereby direct the safety shield 610 to an initial rest position bymeans of the biasing force. However, when a sufficient force is appliedto the safety shield 610, the biasing force is overcome and the shieldcan be moved in the other direction. For example, when the safety shield610 is brought into contact with the tissue 10, the contact with thetissue drives the safety shield 610 against the biasing force.

The illustrated safety shield 620 includes a pair of side supports 622,624 with a bottom support extending therebetween and containing anopening to permit the suturing needle 101 to pass therethrough as thesuturing needle 101 moves relative to the safety shield 620. As shown,the safety shield 620 is preferably a simple structure and therefore,the side supports 622, 624 can be substantially hollow and includeopenings formed therein. The bottom support also serves to space the twoside supports 622, 624 apart from one another. In one embodiment, a tab625 can be provided between the side supports 622, 624 and serves toblock contact with the sharp end 103 of the needle 101. The tab 625represents a physical structure that lies adjacent the sharp end 103 andthus effectively blocks the user from lateral access to the sharp end103.

In one embodiment, at least one of the safety shields 610, 620 rotatesrelative to the handle (e.g., the cam shaft 340) when the device 100 ispressed with sufficient force against the patient's tissue. During theoperating state of the device 100 when the device 100 and the safetyshield mechanism 600 are rotated, the suturing needle 101 isprogressively and safely exposed such that it can penetrate thepatient's tissue 10. The various positions of the suturing needle 101and safety shield mechanism 600 are described in more detail below. Inthe illustrated embodiment, the second shield 620 also rotates relativeto the handle and relocates to the needle exit location of the patient'stissue 10 in order to protect the user from the sharp end 103 of theneedle 101.

Each of the illustrated first and second safety shields 610 is biasedwith a biasing member, such as a spring, to thereby direct the safetyshield 610 to an initial rest position by means of the biasing force.However, when a sufficient force is applied to the safety shield 610,620, the biasing force is overcome and the safety shield(s) moves.

The shields 610, 620 are merely exemplary and the shields can take anynumber of different forms so long as they perform the intended function.For example, the shields can be constructed from a frame-work of formedwire or plastic and can be formed of one or more components and itsrotation may be constrained by a spring or other suitable means asshown. Further, the spring element may be integral to the framework,e.g., a wire form constructed of spring tempered steel or nickeltitanium alloy which possess substantial elasticity. It features aspring bias that predisposes the shield towards covering the needlepoint when the device is in its ready to penetrate configuration.

In one aspect of the present invention, each of the handle, the needletransfer mechanism 400, the safety shield mechanism 600 rotates aboutthe same common axis, namely, the axis defined by the cam shaft 340. Asa result, the safety shields 610, 620 are coupled to the cam shaft 340in a rotatable manner. It will be understood that the above arrangementis merely exemplary in nature and that one or more of the abovestructures can pivot (rotate) about a different axis (such as adifferent parallel axis).

Other features and the suturing operation (technique) of the device 100are now discussed with reference to FIGS. 1-7E. FIGS. 7A-7E eliminate anumber of the inner components of the device 100 for sake of simplicityand these figures are generally presented to show the various positionsof the handle, the needle shield mechanism 600 and the needle transfermechanism 400.

FIG. 7A shows the device 100 in an initial (first) position in which thehandle is held in a substantially vertical position with the actuator200 extending upward toward the user so as to be freely accessible. Theneedle 101 is positioned within the device 100 such that the point 103of the needle 101 is positioned in a generally perpendicular orientationto the target tissue 10. This orientation is favorable for tissuepenetration by the needle although shallower approach angles to thetarget tissue could be sufficient for penetration. The spring loadedsafety shields 610, 620 protect the user from accidental NSIs. As shown,in this position, the first safety shield 610 surrounds the sharp tip103 of the needle 101, thereby protecting the user. As discussed in moredetail below, the opposite blunt end 105 of the needle 101 is securelygrasped and held by the needle transfer mechanism 400 and in particular,is held by the first needle gripper 410. The second needle gripper 420is in a stand-by position awaiting the needle transfer action once theactuator is activated.

FIG. 7B shows rotation of the handle (about the cam shaft 340) relativeto the tissue 10 to effectuate the advancement of the suturing needle101 into and through the tissue 10. It will be noted that in this secondposition, the suturing needle 101 is still held by the first needlegripper 410. In addition, the safety shield mechanism 600 rotates so asto position the safety shields 610, 620 in positions against the tissue10 but still in positions to shield the needle 101. In particular, asthe handle is rotated (toward the right in FIG. 7A), the safety shields610, 620 rotate in the position as shown. As mentioned previously, inthis embodiment, both the handle and the safety shields 610, 620 rotateabout the cam shaft 340 to position shield 610 at a location at whichthe needle 101 enters the tissue 10 and shield 620 is positioned at alocation in which the needle 101 exits the tissue after passagetherethrough for protecting the user.

In the position of FIG. 7B, the sharp tip 103 is located immediatelyadjacent the tissue 10 and is ready for advancement therein. One willappreciate that compared to FIG. 7A, the handle has been rotated toassume a first acute angle relative to the tissue 10. To assume thisposition, the user simply rotates the handle to this angled positionrelative to the tissue 10.

From the position of FIG. 7B, the user rotates the handle in a directionthat causes the needle 101 to be progressively driven into the tissue10. The needle 101 is progressively and safely exposed as it penetratesthe patient's tissue 10.

In FIGS. 7A-7C, the handle is rotated toward the left to causeadvancement of needle 101. The handle is thus rotated from the acuteangle of FIG. 7B to another acute angle shown in FIG. 7C.

Of note, during this needle advancement and during entry of the needleinto the tissue 10, the needle 101 is held by the first needle gripper410.

The construction of the device 100 and arcuate shape of the needle 101is such that this rotation of the handle causes the needle 110 tolikewise travel within an arcuate path and be driven into and throughtissue and then subsequently exit the tissue 10 at another location.

FIG. 7C generally shows the movement of the needle transfer mechanism400 to capture and extract the needle 101 after the needle 101 passesthrough the tissue 10 by means of a needle transfer from the firstgripper 410 to the second gripper 420. To transfer the needle 101, theactuator is activated by moving the actuator body 200 in a downwarddirection to cause rotation of the second gripper 420 to a needlereceiving position at which the second gripper 420 can receive the sharpend 103 of the needle 101. In this needle receiving position, the secondgripper 420 is also in an open position to permit reception of theneedle 101. The second gripper 420 thus rotates downward (about camshaft 340) towards the tissue 10 and the needle 101. At the bottom ofthe actuator stroke, the needle 101 is captured by the second gripper420 and is immediately released by the first needle gripper 410. Thespecific actions and operation of the needle transfer mechanism 400 aredescribed in more detail below with reference to FIGS. 1-6 and 8A-8F.

The actuator is then released and the drive (return) mechanism 225causes the actuator body 200 to return to the rest position (actuatorbody 200 moves upward to the initial, rest position). While, theillustrated drive (return) mechanism 225 is a spring based system, itwill be understood that other types of return mechanisms can be used toapply a force to the actuator body 200 to return the body 200 to theinitial rest position. As the actuator body 200 resets itself andreturns to this position, the second gripper 420 is also likewisereturned to its original position (in which the second gripper 420 iscontained within the handle housing). This movement of the secondgripper 420 extracts the captured needle 101 from the patient's tissue10. As shown in the position of FIG. 7D, the first gripper 410 is in astand-by position and the blunt end 105 is free thereof. One willunderstand that the device 100 can be configured to employ an additionalactuator stroke to extract the needle 101. Regardless of the method, theneedle 101 is now free from the patient's tissue and the suture 11 haspenetrated the tissue 10. While the illustrated embodiment shows theactuator body 200 as a proximally configured assembly, the actuator canequally be in the form of a side-mounted button that the user canoperate with his or her palm, finger or thumb.

Turning now to FIG. 7E, to reset the needle transfer mechanism 400 andmove the needle 101 back to the first gripper 410, the actuator is onceagain activated as by pressing the actuator body 200 for returning theneedle 101 back to the original position within the device 100. The userhas the option to cut the suture 11 at this point in time. As shown inFIG. 7E, the actuator body 200 is depressed and the second gripper 420is moved to a distal location relative to the handle (the needle tip 103remains shrouded by the second gripper 420). The first gripper 410 ismoved into an open position thereof, thereby allowing the suture needle101 to be received therein. The second gripper 420 opens to allowrelease of the suturing needle 101 to the first gripper 410.

As part of this actuator stroke, the user releases the actuator body 200and the mechanism 225 causes a return force to be generated and therebymove the actuator body 200 back to the rest position. As the actuatorbody 200 is released, the first gripper 410 moves to its closedposition, thereby grasping the suturing needle 101 within the firstgripper 410 (i.e., the needle 101 has been returned to the originalneedle position). The release of the actuator body 200 causes the secondgripper 420 to rotate back to the original position.

The needle transfer mechanism has thus completed its cycle at this pointin that the suturing needle 101 is first transferred from the firstgripper 410 to the second gripper 420 to pass the suturing needle 101through and extract it from the tissue 10 and then the needle 101 istransferred back to the first gripper 410 to allow additional suturingto occur as shown in FIGS. 7A-7E. Once the suturing needle 101 isreturned to the original position (see FIG. 7A), the user can deliver asecond suture 11 to the patient. The stitches can be of a continuoustype or interrupted.

As shown in FIGS. 7A-7E, throughout the entire operation of the device100, the sharp needle end (tip) 103 of the needle 101 is covered by atleast one of the safety shields 610, 620, shrouded by the second gripper420, or embedded in the patient's tissue 10. At no time is the userexposed to the needle point (end 103). This is one of the advantages ofthe device 100.

FIGS. 1-6 and 8A-8F show the inner working parts of the device 100 inthe various operating positions that are shown in FIGS. 7A-7E. In someof the figures, the safety shield mechanism 600 has been removed forpurposes of clarity and in other figures, other components have beenremoved from view for clarity purposes and to allow other components tobe seen. As discussed previously, the exemplary first and secondgrippers 410, 420 are of a reciprocating nature in that each can movebetween an open position (needle receiving position) and a closedposition (needle grasping position).

FIG. 8A shows the inner components of the device 100 in the initial restposition. In this position, the needle 101 is grasped by the firstgripper 410 and is free of the second gripper 420. The pin 500associated with the first gripper 410 is biased inward towards the camshaft 340 and a proximal portion 105 of the needle 101 is disposedwithin the notch 510 of the pin 500. The biased nature of the pin 500 inthis position causes the needle 101 to be captured by the pin 500 withinthe notch 412 of the first gripper 410. In this position, the needle 101is effectively grasped by the first gripper 410 which as mentionedearlier is fixed relative to the handle. The (drive) return mechanism225 is likewise shown in the non-actuated state since the actuator body200 is in the rest position.

FIG. 8B is a close-up view of the cam shaft 340 and in particular, thecam member 350 thereof in relation to both of the first and second pins500. The cam member 350 engages both of the pins 500 and in this initialposition, the pin 500 associated with the first gripper 410 is shownbeing biased in a direction toward the cam shaft 340 (as indicated bythe arrow). This position of the cam member 350 causes the pin 500associated with the second gripper 420 to be directed outwardly in adirection away from the cam shaft 340 since the force of the cam member350 against the pin 500 overcomes the biasing force of the pin 500associated with the second gripper 420.

As the actuator body 200 is depressed, the cam shaft 340 rotates (cammember 350 likewise rotates) and the pins 500 are translated away fromand back towards the center axis of the cam shaft 340. When either ofthe pins 500 is translated away from the cam shaft 340, it releases thesuture needle 101 and when either of the pins 500 is translated towardsthe cam shaft 340, the gripper grasps and holds the suturing needle 101.One will appreciate that the needle transfer mechanism 400 incombination with the cam action of the cam member (body) 350, thesuturing needle 101 is gripped by one of the first and second grippers410, 420 at all times and cannot become free from the device 100. Theneedle transfer mechanism 400 according to the present inventionprovides safety to the user and others that may come into contact withthe device 100. In addition, this feature is the mechanism 400 thatenables the needle 101 to be shuttled from one gripper 410, 420 toanother in order to facilitate the suturing process in a controlledmanner and based on normal movements of the user, such as traditionalwrist rotation.

Although the embodiment shown in the figures that the needle grippingaction occurs when the pins 500 alternatively translate towards thecenter axis of the cam shaft 340 and the needle release action occurswhen the pins 500 alternatively translate away from the center axis ofthe cam shaft 340, one of skill in the art will understand that thedirections of the needle grasping (clamping) and releasing actions canbe reversed with a modification of the relevant structures.

Now turning to FIG. 8C, the actuator body 200 has been depressed toactivate the actuator and the second gripper 420 engages the sharp end103 of the needle 101. More specifically, as the actuator body 200 isdepressed, the actuator body causes the link arm 270 which is coupledthereto to move downward and at the same time the drive (return)mechanism 225 stores energy due to the biasing member (e.g., a spring)(not shown) associated with the mechanism 225 being compressed. Sincethe link arm 270 is coupled at its distal end directly to the secondgripper 420 (i.e., the body 440) and the second gripper 420 is directlycoupled to the cam shaft 340, the movement of the actuator body 200 isdirectly translated into rotation of the second gripper 420 and in thiscase, the movement of the second gripper 420 is a rotation about the camshaft 340. The gear 300 is driven by the movement of the actuator body200 and this causes rotation of the other gears and this results inrotation of the cam member 350 since the third gear 320 is directlycoupled to the cam shaft 340. This movement (rotation) of the cam member350 causes the reciprocating motion of the pins 500 that is describedabove. This reciprocating movement causes the pins 500 to selectivelyopen and close depending upon the position of the cam member 350 andthis action in combination with the controlled movement of the secondgripper 420 provide a means for effectively transferring the suturingneedle 101 from one gripper to another gripper depending upon theparticular operating stage of the present device 100. As mentionedabove, the pawl 280 and ratchet 290 allow the gears 300, 310, 320 torotate only in one direction.

FIG. 8C thus shows the needle transfer from the first gripper 410 to thesecond gripper 420 after at least the distal sharp end 103 of thesuturing needle 101 has exited the tissue 10. The rotation and positionof the cam member 350 at the time of needle transfer is such that thefirst gripper 410 opens to allow transfer of the suturing needle 101from the first gripper 410 to the second gripper 420 and the secondgripper is initially open to receive the sharp end 103 of the suturingneedle 101. The exemplary positions of the grippers 410, 420 at the timeof the needle transfer are shown in FIG. 8C.

FIG. 8D shows the release of the actuator body 200 and the drive(return) mechanism 225 causes the actuator body 200 to move in adirection away from the needle transfer mechanism 400 (i.e., it resetsthe actuator body 200 to the initial rest position). The release of theactuator body 200 causes the second gripper 420 to rotate back towardsthe handle (i.e., back to the initial rest position of the secondgripper 420). This movement (rotation) of the second gripper 420 causesextraction of the needle 101 from the tissue 10 since the suturingneedle 101 is grasped by the second gripper 420 and remains free fromthe first gripper 410. In this retracted position of the second gripper420, the second gripper 420 can be at least substantially containedwithin the handle. This position is also shown in FIG. 7D. As mentionedabove, the suture 11 can be cut at this time.

As mentioned before, to return the suturing needle 101 to the original,initial position in which the suturing needle 101 is grasped by thefirst gripper 410 and is ready for subsequent advancement into andthrough the tissue 10, the user activates the actuator by depressing theactuator body 200 again (to cause further cycling of the needle transfermechanism 400). Depressing the actuator body 200 causes movement of thelink arm 270 as described above and causes movement of the returnmechanism 225 (to store energy) and these movements result in the secondgripper 420 moving (rotating about the cam shaft 340) in a directiontoward the tissue 10 away from the handle. Since the suturing needle 101is securely grasped by the second gripper 420 during this movement, thesuturing needle 101 is also moved back to its original position. Thismovement of the second gripper 420 moves the needle 101 along an arcuatepath and delivers the blunt end 105 of the needle 101 to the firstgripper 410 and also results in the pin 500 associated with the firstgripper 410 moving to the open (needle receiving) position, therebyallowing the blunt end 105 of the needle 101 to be received within thenotch 412 and the notch 510 of the pin 500. At the same time, at the endof the actuator stroke, the pin 500 of the second gripper 420 moves tothe open position, thereby allowing release of the needle 101.

FIG. 8F shows the release of the actuator body 200 and the return of thesecond gripper 420 to its original, rest position. Once the actuatorbody 200 is released, the drive (return) mechanism 225 drives theactuator body 200 (by releasing its stored energy) to its initial restposition and since the second gripper 420 has released the suturingneedle 101, the needle 101 is grasped by only the first gripper 410 andthe second gripper 420 (which is free of the needle 101) rotates backtowards the handle to its original position.

One alternative embodiment of the present device, which extracts theneedle 101 from the patient's tissue with a rotational handle motion, isconfigured with a second gripper that linearly approaches and grasps theneedle 101 via the partial depression of the actuator, and as theactuator depression continues, the motion of the second gripper abruptlytransitions from linear to rotational and the needle 101 is rotatablyextracted from the patient's tissue. A subsequent actuation of theplunger rotates the needle back to its origin and returns the secondgripper to its original position.

It will be appreciated that other needle transfer mechanisms can be usedto shuttle the suturing needle 101 from one location and from onegripping member to another location and another gripping member.

FIGS. 9A and 9B illustrate front and back views of a two piece safetyshield that can be used with the device 100 for shielding the suturingneedle 101 over its range of motion in the manner described herein. Thefirst safety shield 610 is rotatably coupled to the device handle byshaft (axle) 340 and a torsion spring 800 or other suitable means. Thefirst safety shield is also rotatably coupled to the second safetyshield 620 by a torsion spring or other suitable means. Thus, twosprings 800 are used in this design. The spring-loaded engagementbetween the first safety shield 610 and the handle permits the user torotate this shield 610 relative to the handle and to safely penetratethe patient's tissue with the needle. The spring-loaded engagementbetween the first safety shield 610 and the second safety shield 620forces the latter shield to follow the rotational path of the formerwhile simultaneously providing flexibility between the two shields 610,620. This flexibility enables the shields 610, 620 to adapt to variabletopographies (e.g., tissue, catheter hubs) and still protect the userfrom the point of the needle throughout the operation. Morespecifically, the shields 610, 620 contact the tissue which applies aforce that counters the biasing force of the shields 610, 620, yet thebiasing force of the shields 610, 620 drives the shields 610, 620 intoengagement with the tissue and as shown, when in contact with the tissue10, the shields 610, 620 rest thereagainst at two different (opposite)locations along the tissue 10.

In another contemplated embodiment, the shields 610, 620 can beconstructed as a single piece that features an integral flexible portionthat allows for a similar adaptation to variable topographies.

An additional feature of the safety shield(s) 610, 620 provides the userwith the ability to precisely deliver the needle 101 to the patient.This feature may be a protrusion on one of the shields 610, 620 that,for example, aligns the needle to the suture hole of a catheter hub.This feature may also be a ring, semi-circular structure, or visiblemark on the shield that helps the user to more clearly visualize thedesired needle penetration and/or exit sites upon the tissue. Inparticular, when the second shield 620 seats against tissue, the usercan immediately be aware of where the sharp end 103 of the needle 101will exit the tissue 10.

More specifically, FIG. 12 shows one exemplary alignment feature thatcan be part of at least one or both of the safety shields 610, 620. Asshown in the top plan view of FIG. 12, the alignment feature can be inthe form of a protrusion 950 that extends inwardly from a frame of theshield 610, 620. The protrusion 950 serves as a tool to indicate to theuser the location at which the needle will pass through the shield 610,620 as it is either being driven and advanced into the tissue (as inshield 610) or when it is exiting the tissue and is received within theshield 620. The alignment feature 950 preferably includes alignmentindicia 955 to show the user the precise location at which the needle101 passes through the respective shield 610, 620. In the illustratedembodiment, the indicia 955 consists of three separate markings, namelytwo markings on the sides of the shield's frame and one marking at theend of the shield's frame (however, less than or greater than 3 markingscan be used). The two markings on the sides are opposite one another andtherefore, define a first alignment line and the single end marking alsois used to define a second alignment line that is perpendicular to thefirst alignment line. The point (area) at which the first and secondalignment lines intersect represents the point (area) at which theneedle 101 will pass through the shield. The alignment indicia 955 canbe integral to the shield (i.e., formed in a common mold operation) orcan be added in a secondary operation, such as pad printing, adding adecal or laser etching.

FIG. 12 shows the shield 620 since in this view, the needle 101 haspassed through the tissue and is being passed through a suture hole 970that is formed in a catheter hub of a catheter 960 for placement andsecurement on the tissue of the patient using the suture. Theillustrated catheter hub includes a main catheter tube and a pair ofextension tubes shown partially in the figure. As a result, thealignment feature 950 associated with second shield 620 serves toindicate to the user the location of the needle tissue-exit site.However, the first shield 610 also preferably includes the alignmentfeature 950 for indicating to the user the location at which the needle101 passes through the first shield 610 prior to entering the tissue,etc. This allows the user to align the device properly relative to atarget by positioning the shield 610 at the desired location at whichthe needle 101 will be driven into the target. In the example of FIG.12, the alignment feature 950 of the first shield 610 is aligned withone suture hole 970 of the catheter hub and then the needle 101 isadvanced and passes through the first shield 610 and through the suturehole 970 before entering the tissue.

It will be understood that the alignment feature can be used to alignthe shields 610, 620 with target points on tissue itself in applicationsnot involving a catheter (i.e., applications in which tissue is directlysutured).

Additional safety can be provided to the user through a safety shieldlockout feature, which prevents the shield(s) from rotating and therebyexposing the needle to the user, even when pressure is exerted upon theshield(s). FIGS. 13-15 illustrate a lockout mechanism 1000 in accordancewith one embodiment of the present invention. The lockout mechanism 1000is designed to prevent the user from accidentally exposing the needleand obtaining an NSI. The lockout mechanism 1000 can take the form of auser-actuated button, lever, slide, or other similar means and aconnecting element that couples the actuation means and the safetyapparatus. The button causes the connecting element to lock and unlockthe apparatus in a variety of ways. Examples of these means includetongue and groove, intermeshing gears, friction and interference fits,inclined panes, cantilever, and screws. In each of these methods, theconnecting element restricts the movement of the apparatus, andtherefore, the exposure of the needle until the user actuates the buttonto release the apparatus. A lockout mechanism in the form of a slideablebutton (FIG. 13A) engages one or both of the safety shields 610 and 620such that the shields 610, 620 will not expose the sharp distal point103 of the needle 101 to the user. When the button is pressed andunlocks safety shields 610 and 620, the suturing device and safetyshields can be rotated such that the needle 101 is progressively andsafely exposed in order to penetrate the patient's tissue in the mannerdescribed herein with reference to the various suturing devices of thepresent invention.

FIG. 13A depicts a magnified view of the distal end of a suturing deviceaccording to any one of the embodiments described and illustratedherein. In other words, the lockout mechanism 1000 can be incorporatedinto any of the suturing devices disclosed herein. The lockout mechanism1000 consists of a lockout button (actuator) 1010, which is pivotallyattached to the handle body 1020 by pin 1030, and a lockout linkage 1040which can be in the form of an elongated beam like structure having afirst (proximal) end 1042 and an opposing second (distal) end 1044. Itwill be understood that the actuator 1010 is the same as actuator 110and the body 1020 is the same as body 120 when the lockout mechanism isemployed in device 100. The linkage 1040 slides generally longitudinallywithin a channel in the handle body and alternatingly between locked andunlocked positions of safety shields 610 and 620. The linkage 1040 hasan attached drive pin 1050 at the first end 1042, legs 1060, and feet1070 extending outwardly from distal ends of the legs 1060. A spring(not shown) biases the linkage 1040 distally and locks shield 620 fromrotating. When button 1010 is pressed, its ramp-like surface guides thedrive pin 1050 proximally, which in turn extracts the beam feet 1070from lock notches (openings) 1080 in safety shield 610 and allows theshield 610 to rotate. Once the shield 610 begins to rotate, the beamfeet 1070 cannot reengage the shield 610 until the shield returns to itsready mode position and the lockout button 1010 is released.

Looking now at FIG. 13B, the suturing device has been manipulated suchthat the lockout mechanism 1000 has been deactivated (unlocked), theshields 610 and 620 have rotated, the needle (not shown) has entered andexited the patient's tissue 10. In this deactivated or unlocked state,the shields 610, 620 can rotate.

Once the suturing device is drawn away from the patient and the sutureremains in the patient's tissue 10, the lock out button 1010 can bereleased and returned to its default position and safety shields 610,620 are restricted from rotating. The suturing device has thus beenplaced back into the locked position.

It will be understood that the illustrated lockout mechanism is merelyexemplary in nature and other mechanical structures can be provided toachieve the intended lockout functionality.

The device 100 also preferably includes a means for cutting the suture11. FIG. 10 shows a suture cutter 940 that is integral to the handlewould provide the user with a means to cut and trim suture during theprocedure. Any number of different types of cutting members can be usedand in the illustrated embodiment, the suture cutting 940 is providedwithin the handle. The suture cutter 940 includes a cutter guide notchor slot 810 that receives and stabilizes the suture 11.

As depicted in FIG. 10, the cutter is an internal dynamic shearingapparatus, i.e., scissors or slideable blade(s), that would require theuser to press or slide a button 942 in order to activate the blade 944to cut the suture. Any number of different types of cutter actuators canbe used including but not limited to the button 942 (as shown), a slide,lever or other structure that is coupled to the blade 944 such thatmovement of the actuator is translated into movement of the blade 944sufficient to generate a cutting force that cuts the suture 11 containedwithin the notch 810.

The button (actuator) 942 is connected to a means that translates theblade 944 across the suture 11. It will be appreciated that the blade944 is constrained by a set(s) of parallel faces (distal and proximal tothe suture cutting locus) to ensure alignment of the blade as itapproaches the suture, cuts the suture, and its forward stroke beyondthe point of cutting. This means could be a slideable track if thebutton were to slide in the direction of the blade 944, or a pair ofmatched ramps that would convert the vertical motion of the depressedbutton to a horizontal motion of the cutting blade. A spring or othersuitable means would return the button 942 to its original position.Further, the suture would be positioned in a notch, slot, or hole 810 onthe outer surface of the housing. Alternatively shown in FIG. 11, thecutter can be a simple apparatus such as a static cutting blade 945located near the exterior surface of the handle. The blade 945 can beaffixed in a narrowing, crevice-like feature 947 that is sized so thatthe suture 11 can be drawn across the blade's sharp edge in order to cutit however direct access to the blade by the user is not possible due tothe crevice's narrow pathway. These features would reduce or eliminatethe need for the user to provide a pair of scissors for the suturingprocedure.

It will therefore be appreciated that in one exemplary use and accordingto one exemplary design, the suturing needle 101 is manually advanced bya rotation of the handle from a first position at which the handle is ata first acute angle relative to the tissue 10 to a second position atwhich the handle is at a second acute angle relative to the tissue 10.The rotation (pivoting) of the handle from the first to the secondpositions causes the suturing needle 101 to be driven into the tissue 10and pass through the tissue 10 to a tissue exit location at which thesuturing needle 101 can be grasped and extracted from the tissue 10. Toshuttle (transfer) the needle 101 between its various operatingpositions, the actuator is activated to cause transfer of the needle 101from the first gripper 410 to the second gripper 420 which then activelygrasps and extracts the needle 101 from the tissue. This completes onesuturing action (cycle) in that the needle 101 has been driven into,through the tissue and extracted from the tissue 10. To begin a nextsuturing action, the needle 101 is returned (shuttled) to the firstgripper 410 and assumes its original position.

The present needle transfer mechanism 400 thus provides an effectivemeans for passing the needle 101 through the tissue 10 for suturingthereof, while at the same time, the complementary safety shieldmechanism 600 shields the user from the sharp end 103 of the needle 101.

Now turning to FIGS. 14-17, a suturing device 1100 according to anotherembodiment of the present invention is illustrated. For clarity andsimplicity, a number of components of the suturing device 1100 are notshown but are shown in the previous figures and therefore, it will beunderstood that the device 1100 can and preferably does include one ormore of these features, mechanisms, etc. For example, the safety shields610, 620 and suture cutter 940 have also been removed for thisillustration, as their operation is detailed in other figures. Further,a number of ribs, screws, and other basic features of the body of thedevice are also not shown. When these features are important to theoperation of the device, they will be described accordingly.

As with device 100, the device 1100 includes an actuator 1110 themovement of which controls a number of the operative parts of the device1100. FIGS. 14-16 depict three stages of the actuator 1110 travel(namely, home, partial stroke, full stroke positions) and the resultingmovement of the device's primary internal components. The proximal endof the device is defined by the actuator 1110 which can take any numberof different forms. The actuator body is such that the user can easilyaccess and manipulate the actuator body as by pressing the actuator bodydownward as in the previous embodiment. The actuator 1110 includes anactuator rack 1120 which is designed to engage a main drive gear 1130which is rotatably disposed within the housing (handle) of the device1100.

The main drive gear 1130 in turn engages a main drive wheel 1140 whichis also rotatably disposed within the housing. The connection betweenthe main drive gear 1130 and the main drive wheel 1140 can be in theform of a one directional ratcheting or clutching mechanism. A varietyof means for ratcheting or clutching may be used, including a simpleramped and spring loaded interface between the gears or a torque springclutch type mechanism. Other types of clutches may be used instead. Thenet effect of the drive gear 1130 and drive wheel 1140 interaction isthat on the down-stroke of the actuator 1110, the gear 1130 drives thewheel 1140, while on the subsequent up-stroke of the actuator the gear1130 disengages from the wheel 1140 and the drive wheel 1140 thereforeremains stationary.

The actuator 1110 of FIG. 14 also includes an elongated spring rod 1160,which is connected to the actuator 1110 by a suitable means, and slidesthrough a tight-clearance bearing 1170. The spring rod 1160 is alsoconfigured to support a long compression spring 1162, which is locatedbetween the bearing 1170 and the proximal end of the actuator 1110. Thespring rod 1160, bearing 1170, and compression spring 1162 together biasthe actuator 1110 proximally and automatically return the actuator 1110after each completed actuator depression. In other words, thesecomponents generate a return force for returning the actuator the rest(home) position.

The main drive wheel 1140 has an elongated reciprocating linkage 1180,which is pivotably attached to the drive wheel 1140 by a pin 1182 orother mechanism. The reciprocating linkage 1180 is further connected toa reciprocating rack assembly 1190. The reciprocating rack assembly 1190is made up of a receiving side rack 1192 and a delivery side rack 1194.The reciprocating rack assembly 1190 and the individual racks 1192, 1194thereof ride on a number of ribs (not shown) which are part of thehandle of the suturing device 1100. The ribs are configured such thatthe rack motion is constrained in a single vector which is roughlyparallel to the longitudinal axis of the device. A single such rib 1121is depicted in order to illustrate the concept. The receiving side rack1192 is connected to a receiving shuttle assembly 1200, which will bedescribed in detail shortly.

The actuator rack 1120, main drive gear 1130, and main drive wheel 1140are configured such that one completed actuation of the actuator 1110rotates the drive gear 1130 and drive wheel 1040 180 degrees. In thismanner a single stroke moves the reciprocating rack assembly 1190 fromits proximal most location to its distal most location. A secondcomplete stroke would return the rack assembly to its initialconfiguration.

The receiver shuttle assembly 1200 of FIG. 14 includes a receivershuttle body 1210, a sliding rack 1220, and a pinion screw 1230. Thepinion screw 1230, illustrated as a simple pinion gear for clarity, isessentially a simple screw with a pinion gear head. The pinion screw1230 has a right handed thread. The sliding rack 1220 sits inside agroove in the receiver shuttle body 1210, such that sliding rack 1220 isconstrained in all directions except for along the axis of the slidingrack 1220 itself. The rack 1220 and screw 1230 are mated such that thesliding motion of the rack 1220 along its track translates to a rotationof the screw, which in turn actuates the screw into or out of the pageof FIG. 14.

The receiver shuttle body 1210 is an elongated structure designed to beinjection or cast molded or formed using another technique. At thedistal end of the receiver shuttle body 1210 a slot runs across thewidth of the body. The slot is positioned roughly at the center point ofthe thickness of the receiver shuttle body, and is configured such thata needle may fit inside the slot. The slot feature of the shuttle bodyextends proximally well past the pinion screw 1230. The pinion screw1230 is threaded into a complementary hole formed in the shuttle body1210. The hole only exists on one side of the slot and not the other,such that the motion of the screw 1230 is limited and will bottom out onthe surface of the other side of the device tightened accordingly. Theshuttle body 1210, slot, pinion screw 1230, and threaded hole are allconfigured such that the shuttle body 1210 can slide over the needle101, which fits into the slot, and then clamped by the end of the pinionscrew 1230, in a manner that is similar to a bench vise. The clampingaction of the pinion screw 1230 is sufficient to tightly secure theneedle 101 in the handle.

At the proximal end of the receiver shuttle body 1210 of FIGS. 14 and15, a rectangular pin 1240 is shown, as well as a series of gear teeth1250. As described above, the gear teeth 1250 of the receiver shuttlebody 1210 are mated with the receiving side rack 1192 in the typicalrack and pinion type configuration. The proximal most end of the slidingrack 1220 features a rack pin 1221. The rectangular pin 1240, which is around pin featuring a pair of parallel, flat edges, and the rack pin1221 both ride between a number of ribs, which together create a welldefined path that allows for a controlled motion of the two parts. Theexact motion of the receiver shuttle assembly 1200 and the constituentparts are best described in a later drawing. For now it is sufficient toknow that the motion of the sliding rack and rectangular pin are welldefined and controlled. Furthermore it is important to understand thatthe receiver shuttle assembly is driven by the travel of the actuator.This travel translates into the actuation of the receiver shuttleassembly 1200 by way of the main drive wheel 1140, linkage 1180, andreciprocating rack assembly 1190.

Referring to FIGS. 15 and 16, a second pinion screw 1241 is depictednear the proximal end of the needle 101. In order to differentiate thetwo pinion screws the second pinion screw 1241 will be referred to asbeing the delivery pinion screw. This pinion screw 1241 acts to clampthe proximal end of the needle 101 in the same way that the first pinionscrew works to clamp the distal end of the needle 101 as describedabove. The pinion screw 1241 is configured such that the screw willinteract with delivery side rack 1194. The delivery side rack 1194 isconnected to the receiving side rack 1192 by way of a pin 1193, whichextends from the receiving side rack 1192 and fits into a slot of thedelivery side rack 1194. The pin 1193 can slide along the slot; howeverit is ordinarily biased to one direction with the aid of a compressionspring (not shown).

Referring particularly to FIGS. 15-17, a simplified view of the distalend of the device has been shown. The purpose of this figure is toillustrate the path that the receiver shuttle assembly 1200 takes duringthe actuation of the device. As depicted, two distinct and separatepaths are created by slots and ribbed features within the body of thehandle. The central rectangular pin path 1300 guides the travel of thereceiver shuttle body 1210. The rectangular pin 1240 of the shuttleassembly travels in a specific orientation, which is constrained by thewidth of the central rectangular pin path 1300. The path maintains arelatively constant width throughout its length except for the mostdistal region where the path changes rapidly to a full diameter, whichis wider than the proximal width of the path and permits the previouslyconstrained rectangular pin to rotate within. The practical effect isthat the receiver shuttle body 1210 moves exclusively in an axialdirection during specific parts of the device cycle and then rotates inwhile in others. It is through these movements by the receiver shuttlebody that the needle is gripped, released, extracted from tissue, andreturned to its origin.

Still referring to FIG. 17, a compound rack guiding path 1310 isdepicted. This compound path is configured to constrain the rack pin1221 of the receiver shuttle assembly 1200. The path has two distinctbut connected sections: a linear section 1312, and an arcuate section1314. The linear section 1312 of the path 1310 is parallel and analogousto the linear section of the rectangular pin path 1300. The relativepositions of the two paths are configured such that when the rectangularpin 1240 is prevented from rotating about its axis the rack pin 1221 isonly permitted to move in the axial direction within the arcuate section1314. When the rack pin 1221 initially enters the curved (arcuate)section 1314 of the rack pin path, the rectangular pin 1240 has not yetentered the distal-most, diametral region of its respective path 1300.Next, as the user continues to depress the actuator 1110, the receivershuttle body 1210 continues to travel linearly along its path while therack pin 1221 is simultaneously constrained at the base of the straightsection. This results in relative motion between the sliding rack 1220and the receiver shuttle body 1210. The relative motion continues untilthe rectangular pin 1240 enters the distal most, diametral region of therectangular pin path 1300. At this point, the rectangular pin 1240 isable to rotate about its axis, and this rotation in turn translates tothe travel of the rack pin 1221 through the arcuate section 1314 of therack pin path 1310. The relative motion between the sliding rack 1220and the receiver shuttle body 1210 creates the synchronized rotation ofthe pinion screw 1230 that leads to it gripping the needle 101. Thisneedle gripping action occurs prior to the rotation of the receivershuttle body 1210 about its axis, and that enables the receiver shuttleassembly to automatically extract the needle 101 out of the tissue 10 asthe actuator 1110 is depressed. At this point, the needle 101 and suturehave penetrated and exited the patient's tissue 10.

A ratchet mechanism 1320 is designed to prevent the receiving shuttlerack pin 1221 from moving into the linear section 1312 of its path 1310during the return stroke. The pin 1221 is prevented from moving whilethe receiver shuttle body is allowed to continue moving in its verticalpath. This creates a relative motion between the sliding rack 1210 andthe receiving pinion screw 1230 which in turn releases the distal end ofthe needle 101. The relative motion of the rack 1210 continues until therack bottoms out in its cavity in the receiver shuttle assembly 1200.When this happens, the ratchet 1320 is over-come by the rack 1210 at itsfull travel or when the ratchet is manually disengaged by the user.

FIGS. 14-17 thus show an alternative shuttle mechanism for grasping theneedle 101 both before and after the needle passes through the tissue tocomplete a suturing operation. The shuttle mechanism in this alternativeembodiment is an active mechanism that captures the needle after itpasses through the tissue as shown in the figures. The pinion screws1241, 1230 represent needle gripping elements and rotation thereofcauses either release or capture of the suturing needle. These needlegripping elements thus include different positions including a needlereceiving position and a needle gripping position.

Similar to the device 100, the device 1100 utilizes wrist motion of theuser to advance the needle initially into and through the tissue asshown in FIGS. 14-17.

In accordance with the embodiment of FIGS. 14-17, a device for suturingtissue includes a handle and a suturing needle having a first pointedend and an opposite second end. The device includes an actuator and alinkage for operatively connecting the actuator to a needle transfermechanism that is configured to transfer the suturing needle between aninitial first (home) position in which the suturing needle is graspedand positioned for advancement into and through the tissue and a secondposition in which the suturing needle is grasped by a moveable shuttlebody and actively extracted from the tissue. The needle transfermechanism is of a reversible type (similar to device 100) to allow theneedle to be transferred back to the first position from the secondposition. The shuttle body moves according to at least two distinctphases, namely, a first phase in which the shuttle body movesexclusively in an axial direction (e.g., along a longitudinal axis ofthe handle) and a second phase in which the shuttle body rotates,wherein the shuttle body grips the suturing needle prior to its rotationwhich causes extraction of the suturing needle from the tissue. Theshuttle body moves according to both the first and second phases in oneactuator cycle (i.e., depressing the actuator body once) and thus, theextraction of the needle (by the shuttle body moving to the secondposition) is effectuated directly by motion of the actuator body.

While the invention has been described with reference to exemplaryembodiments, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the scope of the invention. Inaddition, many modifications may be made to adapt a particular situationor material to the teachings of the invention without departing from theessential scope thereof. Therefore, it is intended that the inventionnot be limited to the particular embodiment disclosed as the best modecontemplated for carrying out this invention, but that the inventionwill include all embodiments falling within the scope of the appendedclaims.

What is claimed is:
 1. A device for suturing tissue comprising: a handle including a housing having a distal end and an opposite proximal end; a suturing needle for advancing a suture through the tissue, the suturing needle having a first pointed end and an opposite second end; a first needle gripper coupled to the housing, wherein the first needle gripper includes a biased pin and is movable between a first position in which the suturing needle can freely move relative thereto and a second position in which the suturing needle is held by the first needle gripper, wherein the movement of the biased pin results in grasping and releasing of the suturing needle; a second needle gripper coupled to the housing, the second needle gripper being movable between a first position in which the suturing needle can freely move relative thereto and a second position in which in the suturing needle is held by the second needle; an actuator disposed within the housing and operatively coupled to the second needle gripper for moving the second needle gripper between the first and second positions; and a safety mechanism coupled to the housing and configured for shielding the pointed end of the needle; wherein prior to insertion of the suturing needle into the tissue, the suturing needle is held by the first needle gripper and subsequent to passage of the suturing needle through the tissue and upon activation of the actuator, the suturing needle is released from the first needle gripper and is captured and held by the second needle gripper to allow retraction of the suturing needle from the tissue; wherein the first needle gripper is fixedly attached to the housing, while the second needle gripper is rotatable about a first axis, wherein rotation of the second needle gripper in a first direction towards the tissue allows capture of the suturing needle after the suturing needle exits the tissue and subsequent rotation of the second needle gripper about the first axis in an opposite second direction away from the tissue causes retraction of the needle from the tissue, the handle also being rotatable about the same first axis.
 2. The device of claim 1, wherein the suturing needle is held by at least one of the first and second grippers at all times and the second gripper at least partially surrounded by the safety mechanism in that the second gripper pivotally travels within a hollow interior space defined by a frame of the safety mechanism.
 3. The device of claim 1, wherein the first needle gripper holds the suturing needle proximate the second end and the second needle gripper holds the suturing needle proximate the first pointed end.
 4. The device of claim 1, wherein the second needle gripper is configured to move to a position in which the suture needle is captured and retained by the second needle gripper, the first pointed end of the suturing needle is contained within the housing.
 5. The device of claim 1, further including a cam shaft disposed along and rotatable about the first axis, wherein contact between the cam shaft and the biased pin causes the reciprocating movement of the biased pin between the first and second positions, thereby allowing the suturing needle to be transferred between the first and second needle grippers.
 6. The device of claim 1, wherein the actuator and the first and second needle grippers are configured such that subsequent activation of the actuator, after the suturing needle has been captured by the second needle gripper, causes rotation of the second needle gripper back in the first direction to effectuate transfer of the suturing needle from the second needle gripper back to the first needle gripper, thereby allowing the suturing needle to be again driven into and through the tissue.
 7. The device of claim 6, wherein during transfer of the suturing needle from the second needle gripper to the first needle gripper, the second needle gripper assumes the first position and the first needle gripper assumes the second position causing the suturing needle to be held by the first needle gripper.
 8. The device of claim 1, wherein activation of the actuator causes each of the first and second needle grippers to move in a reciprocating manner between the first and second positions and causes the second needle gripper to rotate about a first axis to a needle transfer position, the handle also being rotatable about the same first axis.
 9. The device of claim 8, further including a drive assembly for moving the second needle gripper about the first axis and causing the first and second needle grippers to move between the first and second positions, the drive assembly including a cam shaft that is disposed along and rotatable about the first axis and a linkage for operatively coupling the actuator to the cam shaft, whereby activation of the actuator is translated into rotation of the cam shaft.
 10. The device of claim 9, wherein the linkage comprises a plurality of gears and a link arm that connects the actuator to the drive assembly, wherein movement of the actuator drives the link arm and causes rotation of the gears and rotation of the cam shaft which in turn causes the first and second needle grippers to move in a reciprocating manner and thereby causes each needle gripper to assume one of the first and second positions.
 11. The device of claim 10, further including a mechanism that engages at least one of the gears to ensure that the gears rotate only in one direction.
 12. The device of claim 8, wherein the safety mechanism is rotatable about the first axis, the rotation of the safety mechanism being independent from rotation of the second needle gripper about the same first axis which is perpendicular to a longitudinal axis of the handle.
 13. The device of claim 12, wherein the safety mechanism comprises a spring biased shield that shrouds the suturing needle during needle penetration and when the suturing needle exits the tissue, the shield being rotatable about the first axis, wherein the shield comprises a first substantially hollow shield member and a second substantially hollow shield member spaced from the first shield member.
 14. The device of claim 13, wherein the first and second shields can be positioned generally 180 degrees apart from one another.
 15. The device of claim 12, wherein at least one of the first and second shield members includes an alignment feature for indicating to a user a location at which the first pointed end of the needle passes through the respective shield, the alignment feature including alignment indicia that defines the location.
 16. The device of claim 1, further including a lockout mechanism including a lockout deactivating element for deactivating the lockout mechanism, a lockout element and means to connect the actuator element to the lockout element, wherein the lockout element is configured to prevent the safety mechanism from exposing the first pointed end until the lockout mechanism is deactivated.
 17. The device of claim 1, further including a suture cutter disposed within one of the handle and the actuator, the cutter including a slideable blade, an actuator, and a notch to align the suture for cutting.
 18. A device for suturing tissue comprising: a handle having a distal end and an opposite proximal end and being rotatable about a first axis; a suturing needle having a first pointed end and an opposite second end; a needle gripping mechanism disposed within the handle and including first and second needle grippers, wherein the first needle gripper includes a first biased pin and is movable between a first position in which the suturing needle can freely move relative thereto and a second position in the first biased pin of the first needle gripper intimately contacts and applies a biasing force to the suturing needle resulting in the suturing needle being is securely held by the first needle gripper; a second needle gripper coupled to the handle, wherein the second needle gripper includes a second biased pin and is movable between a first position in which the suturing needle can freely move relative to the second needle gripper and a second position in which the second biased pin of the second needle gripper intimately contacts and applies a biasing force to the suturing needle resulting in the suturing needle being securely held by the second needle gripper; and an actuator disposed within the handle and operatively coupled to the needle gripping mechanism for shuttling the suturing needle between the first and second grippers, wherein the actuator is configured such that a single actuator cycle resulting from operating of the actuator causes both the first and second needle grippers to move between the first and second positions; wherein in a first operating position prior to insertion of the suturing needle into the tissue, the handle is positioned at a first acute angle relative to a tissue surface and the device is configured such that movement of the handle about the first axis from the first position to a second operating position in which the handle is positioned at a second acute angle relative the tissue surface causes the suturing needle to be driven into and through the tissue and permits capture of the first pointed end by the second gripping element upon activation of the actuator.
 19. The device of claim 18, further including a safety mechanism coupled to the handle and configured for shielding the first pointed end of the needle.
 20. The device of claim 18, further including a drive assembly for moving the second gripper about the first axis and causing the first and second grippers to move between the first and second positions, the drive assembly including a cam shaft that is disposed along and rotatable about the first axis and a linkage for operatively coupling the actuator to the cam shaft, whereby activation of the actuator is translated into rotation of the cam shaft.
 21. The device of claim 20, wherein the linkage comprises at least one gear and a link arm that connects the actuator to the drive assembly, wherein movement of the actuator drives the link arm and causes rotation of the gears and rotation of the cam shaft which in turn causes the first and second grippers to move in a reciprocating manner and thereby causes each needle gripper to assume one of the first and second positions depending upon a position of the cam shaft.
 22. The device of claim 20, wherein the safety mechanism is rotatable about the first axis, the rotation of the safety mechanism being independent from rotation of the second gripper about the same first axis.
 23. A device for suturing tissue comprising: a handle having a distal end and an opposite proximal end and being rotatable about a first axis; a suturing needle having a first pointed end and an opposite second end; a needle shuttle mechanism coupled to the handle and including a first part and a second part, each of the first and second parts being movable between a needle release position in which the suturing needle can freely move relative thereto and a needle retaining position in which the suturing needle is captured and held thereby, the second part being rotatable about the first axis; an actuator disposed within the handle and operatively coupled to the needle shuttle mechanism for causing the suturing needle to be shuttled between the first and second parts to permit the suturing needle to be driven into and passed through the tissue; and a spring biased safety mechanism coupled to the housing by a spring and configured for shielding the pointed end of the needle, the safety mechanism being rotatable about the first axis independent from the rotation of the needle shuttle mechanism about the same first axis, wherein the first axis is perpendicular to a longitudinal axis of the handle.
 24. The device of claim 23, wherein the handle is configured to rotate about an axle that defines the first axis such that prior to insertion of the suturing needle into the tissue, the handle is positioned at a first acute angle relative to a tissue surface and the device is configured such that rotation of the handle about the first axis to a different position, in which the handle is positioned at a second acute angle relative the tissue surface, causes the suturing needle to be manually driven into and through the tissue and permits capture of the first pointed end by the second part upon activation of the actuator.
 25. The device of claim 24, wherein successive activations of the actuator cause rotation of the second part about the first axis and depending upon an operating state of the second part either causes capture of the suturing needle by the second part or release of the suturing needle by the second part to allow capture of the suturing needle by the first part and permit return of the suturing needle to the first part, thereby allowing the suturing needle to be again driven into the tissue.
 26. The device of claim 24, wherein the first and second acute angles are at least 90 degrees apart from one another.
 27. A device for suturing tissue comprising: a handle having a distal end and an opposite proximal end and being rotatable about an axle that extends along a first axis, in response to rotational movement of a user's hand; a suturing needle having a first pointed end and an opposite second end; a needle transfer mechanism coupled to the handle and including a first part and a second part, the second part being rotatable about the first axis to move between a retracted rest position and an extended needle transfer position, the needle transfer mechanism being constructed such that the suturing needle is initially held by the first part prior to contact between the suturing needle and the tissue, wherein the first part includes a biased pin that is configured to grasp the suturing needle by applying a biasing force to the suturing needle; and an actuator disposed within the handle and operatively coupled to the needle transfer mechanism for moving the second part between the retracted rest position and the extended needle transfer position and effectuating transfer of the suturing needle between the first and second parts, wherein the actuator is operatively connected to both the first and second parts; wherein the needle transfer mechanism is configured such that when the suturing needle is held by second part, it is completely free of the first part and the needle transfer mechanism is configured to transfer the suturing needle from the second part back to the first part.
 28. The device of claim 27, wherein prior to insertion of the suturing needle into the tissue, the handle is positioned at a first acute angle relative to a tissue surface and the device is configured such that rotation of the handle about the first axis to a different position, in which the handle is positioned at a second acute angle relative the tissue surface, causes the suturing needle to be manually driven into and through the tissue and permits capture of the first pointed end by the second part upon activation of the actuator.
 29. The device of claim 27, wherein each of the first and second parts include a needle receiving channel formed therein, wherein a shape of the needle receiving channel is complementary to a shape of the suturing needle so as to prevent rotation of the suturing needle within the needle receiving channel.
 30. A device for suturing tissue comprising: a handle having a distal end and an opposite proximal end and being rotatable about a first axis; a suturing needle having a first pointed end and an opposite second end; a needle transfer mechanism coupled to the handle and including a first part and a second part, the second part being rotatable about the first axis to move between a rest position and a needle transfer position, the needle transfer mechanism being constructed such that the suturing needle is initially held by the first part prior to contact between the suturing needle and the tissue; an actuator disposed within the handle and operatively coupled to the needle transfer mechanism for moving the second part between the rest position and the needle transfer position and effectuating transfer of the suturing needle between the first and second parts, wherein the needle transfer mechanism is configured to return the suturing needle from the second part to the first part after removal from the tissue and upon motion of the actuator which causes the second part to assume the needle transfer position; and a safety mechanism coupled to the housing and configured for shielding the pointed end of the needle, wherein the safety mechanism comprises a spring biased structure that rotates about the first axis and includes first and second shields that are spaced apart and positioned at an angle relative to one another.
 31. The device of claim 1, further including a suture that is carried by the suturing needle.
 32. The device of claim 1, wherein the first axis is perpendicular to a longitudinal axis of the handle.
 33. A device for suturing tissue comprising: a handle including a housing having a distal end and an opposite proximal end; a suturing needle having a first pointed end and an opposite second end; and a safety mechanism coupled to the housing and configured for shielding the pointed end of the needle, wherein the safety mechanism comprises a spring biased shield that is coupled to the housing by a spring and shrouds the suturing needle during needle penetration and when the suturing needle exits the tissue, the shield being rotatable about a first axis, wherein the shield comprises a first shield member and a second shield member spaced from the first shield member, wherein the first axis is perpendicular to a longitudinal axis of the handle. 